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FDA 510(k) Application Details - K954431
Device Classification Name
System, Balloon, Intra-Aortic And Control
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510(K) Number
K954431
Device Name
System, Balloon, Intra-Aortic And Control
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact
LEO BASTA
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Regulation Number
870.3535
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Classification Product Code
DSP
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More FDA Info for this Product Code
Date Received
09/25/1995
Decision Date
01/11/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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